Devices and methods for directed, interstitial ablation of tissue

ABSTRACT

The invention relates to a catheter device including an optical fiber whose distal end is disposed within a hollow tube with a sharp or syringe shaped distal end, which may be inserted into tissue. The distal end of the optical fiber and the hollow tube are configured so as to emit, by refraction (total internal reflection) or reflection from a metal surface, laser energy at an angle of about 80° to about 90° relative to the longitudinal axis of the optical fiber and hollow tube. A first fluid channel within the distal end portion of the tube enables fluid to be infused to cool the distal end of the tube and to cool and clean the emission face of the optical fiber. A second, relatively larger diameter fluid channel in the tube enables the fluid, flowing through said first channel along with hot gasses from the vaporization of tissue, to exit the device through a second port in the tube, away from the tissue being treated. A vacuum can be applied to the second fluid channel to more effectively remove the infused, cooling fluid and hot gasses from the tissue being treated. Alternatively, the tube can incorporate a distal end portion which can be articulated to allow the insertion of the device into tissue perpendicular to the tissue&#39;s surface, from which laser energy can be emitted forwardly.

FIELD OF THE INVENTION

[0001] The invention entails devices and methods for selectivelyvaporizing unwanted body tissues, such as excess tissue in the maleprostate gland or a tumor, without damaging adjoining tissues.

BACKGROUND OF THE INVENTION

[0002] Benign prostatic hyperplasia or “BPH”, commonly referred to as anenlarged prostate, affects more than 50% of men over age 55 and is aworldwide problem. Approximately 200,000 surgeries to treat thiscondition are presently performed each year in the United States at acost estimated at $1.6 billion annually. While pharmaceuticals, such asterazosin, may limit prostate growth for a period of time, eventually asurgical solution may be required.

[0003] The long standing surgical procedure for treating BPH istransurethral resection of the prostate or TURP, in which anelectrosurgical loop heated by radiofrequency (“RF”) energy is moved toand fro within the prostate to resect (cut out) troughs of prostatetissue. While a TURP produces satisfactory voiding of urine, it requiresgeneral anesthesia and an hour or more of costly operating room time andentails up to 15% impotence, 5-10% permanent incontinence and bleedingrequiring a transfusion in up to 10% of the patients. In addition, mostTURP patients suffer from retrograde ejaculation, and up to 30% or moreof TURP patients experience an infection or other adverse effect.

[0004] Recently, high powered RF roller ball devices have beenintroduced, which have somewhat reduced the bleeding and other adverseeffects of a TURP. However, the use of RF roller ball devices requiresgeneral anesthesia and an hour or more of costly operating room time.Holmium lasers can be used for resection of the prostate, producingurine flow results equal to a TURP, while eliminating bleeding and mostof the other adverse effects of the above described procedures using RFenergy. However, Holmium laser resection typically requires one hour ormore of expensive operating room time and general anesthesia.

[0005] The interstitial (within tissue) use of microwave, laser or RFenergy to thermally coagulate a portion of the prostate, while takingless time and avoiding general anesthesia, does not significantly reducethe prostate's volume and thus produces less urine voiding relief than aTURP, high power RF roller ball or Holmium laser resection procedure. Inaddition, the patients treated with interstitial coagulating devicesexperience dysuria and discomfort for weeks after the procedure. If thetissue immediately underlying the urethra, which constitutes theexterior surface of the lobes of the prostate, is coagulated, theurethra dies, due to loss of its blood supply, leaving an open,irritating wound. The coagulated tissue then sloughs off and is excretedin the urine over a period of 3-6 weeks.

[0006] It would be desirable to be able to remove a sufficient amount ofprostate tissue to provide immediate voiding and relief of BPH symptoms,while protecting the urethra and the immediately underlying tissue fromdamage, in a short, outpatient procedure, preferably in an outpatienttreatment facility or a physician's office under local anesthesia and/orsedation.

[0007] Laser or RF energy can be used to coagulate a tumor, butcoagulation occurs irregularly, as conduction of heat through tissue ofdiffering densities and water content is not uniform. Consequently, itis necessary to closely observe the coagulation procedure to avoiddamaging nearby blood vessels, nerves and other vital tissues. While avaporization zone can be distinguished from normal tissue by ultrasoundimaging, coagulated tissue cannot be differentiated from normal tissueby ultrasound imaging. As a result, expensive magnetic resonance imaging(MRI) equipment would be required to visually monitor the coagulationprocedure, so that the process can be halted if the coagulation zoneapproaches important blood vessels, ducts, nerves or other tissues.Unhappily, the use of MRI equipment would increase the cost of analready expensive procedure.

[0008] It would be desirable to be able to accurately vaporize a tumorof any shape, while directing laser energy away from a vital bloodvessel, duct, nerve or other tissue adjoining the tumor, with theability to observe the vaporization process using a less costlyultrasound imaging system.

SUMMARY OF THE INVENTION

[0009] The present invention provides for the vaporization of unwantedtissue in a mammalian body, without producing excessive coagulation ofsurrounding tissues and avoiding thermal damage to a nearby mucosalsurface or an adjacent, important blood vessel, duct, nerve or otherstructure.

[0010] This is achieved by a catheter device adapted to deliver energyfrom a laser source to a body tissue, which device includes an elongate,sharp-ended hollow tube having first and second ports spaced from oneanother, a flexible energy conduit, adapted for connection to a lasersource at its proximal end, a fluid conduit for passing a fluid throughsaid ports for cooling and cleaning the distal end of the energyconduit, and a separate conduit for withdrawing fluid and hot gassesfrom the vaporization of tissue into the hollow tube.

[0011] The fluid can be passed through the ports by positive pressure,and gasses can be withdrawn by vacuum, i.e., negative pressure. Thedistal end of the flexible energy conduit is adapted to emit energy to apredetermined tissue site so as to ablate or vaporize the tissue.

[0012] In one embodiment of the device embodying the present invention,energy, such as laser energy, is transmitted through an optical fiber,whose distal radial end is beveled at an angle about 30° to about 50°,preferably about 39° to about 40°, into a prism-like shape, encasedwithin a quartz or fused silica capillary tube and disposed within ametal tube with a sharp distal end, such as a syringe needle. Encasingthe optical fiber in a capillary tube provides a significant differencein refractive index (air at 1.0 versus quartz or fused silica at about1.33) at the beveled surface, which enables total internal reflection ofemitted energy. As a result, energy is emitted from a port in the metaltube at an angle of approximately 80° to about 90° transverse to theaxis of the optical fiber.

[0013] Two unique fluid channels and ports in the tube enable fluid tobe infused through one channel in the metal tube to cool the distal endportion of the optical fiber as well as the internal face of the distalend of the metal tube, cool and clean the distal closed end face of thecapillary tube from which the energy is emitted. Negative pressureapplied through the other channel in the tube may also be used toevacuate the cooling fluid and the hot gasses from the vaporization oftissue, avoiding the excess coagulation of tissue surrounding the targetarea by thermal conduction.

[0014] An outer sheath of fluorinated hydrocarbon such as Teflon®, aproduct of DuPont de Nemours of Wilmington, Del., other plasticmaterial, or a ceramic may be employed around the sheath containing theoptical fiber to facilitate penetration of tissue, prevent tissueadherence and provide insulation to avoid thermal damage to tissue fromheat conducted along the needle.

[0015] In use, the present device is inserted into tissue and orientedto emit laser energy in a desired pattern, away from a region or tissueto be preserved, such as the mucosa or endothelial surface of an organor an important blood vessel, duct, nerve or other structure, to preventthermal damage thereto. The device can be rotated in an arc whilelasing, or advanced and/or withdrawn while lasing, or both. Such adevice, for example, could be used to vaporize a portion of the lobes ofthe prostate, without damaging the sensitive urethra, or its immediatelyunderlying, supportive tissue, or to vaporize a tumor, without damagingsurrounding normal tissue or a nearby major blood vessel, duct, nerve orother structure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIG. 1 is a side elevational view of a device of the presentinvention;

[0017]FIG. 2 is an enlarged, partial, cross-sectional, side elevationalview of the distal end portion of the optical fiber and the cathetersheath of the device of FIG. 1 terminating in a sharp needle end;

[0018]FIG. 3 is an enlarged, partial, cross-sectional, side elevationalview of the fitting and fluid/vacuum port of the device of FIG. 1;

[0019]FIG. 4(a) is an enlarged, cross-sectional view taken along planeA-A in FIG. 2 showing the manner in which a portion of the sheath isflattened to the optical fiber to create passageways between the sheathand the optical fiber;

[0020]FIG. 4(b) is an enlarged cross-sectioned view illustrating anembodiment where the sheath is crimped to the optical fiber so as tocreate plural passageways;

[0021]FIG. 5 is an enlarged, partial cross-sectional, side elevationalview of the distal end of the device of FIG. 2 depicting the flow offluid therethrough;

[0022]FIG. 6 is an enlarged, partial, cross-sectional, side elevationalview of the distal end of the device incorporating the catheter insertof FIGS. 9 and 10 and depicting an alternate fluid flow patterntherethrough;

[0023]FIG. 7 is an enlarged, partial, cross-sectional, side elevationalview of an alternate embodiment of the handpiece and fluid/vacuumcoupling port of the device of the present invention;

[0024]FIG. 8 is an enlarged, partial, cross-sectional, side elevationalview of another alternate embodiment of the handpiece and fluid/vacuumport of the device of the present invention;

[0025]FIG. 9 is a perspective view of a catheter insert for the tube ofthe device of FIG. 1;

[0026]FIG. 10 is an enlarged, cross-sectional, side elevational viewtaken along the plane B-B in FIG. 11 depicting the tubular catheterinsert positioned in the interior of the tube of the device of FIG. 11;

[0027]FIG. 11 is an enlarged, partial, cross-sectional, side elevationalview of the distal end of the device incorporating the catheter insertof FIGS. 9 and 10 and depicting one selected fluid flow patterntherethrough;

[0028]FIG. 12 is an enlarged, partial, cross-sectional, side elevationalview of the device of FIG. 1 with a sleeve surrounding the tube;

[0029]FIG. 13 is an enlarged, partial, side elevational view of thedevice of FIG. 12;

[0030]FIG. 14 is a enlarged, reduced partial, cross-sectional, sideelevational view of the entire device of FIG. 7, with ports forsimultaneous infusion of fluid and drawing of a vacuum operablyassociated with the handpiece and the fitting, respectively;

[0031]FIG. 15 is an enlarged, partial, non-sectional view of deviceembodying the present invention similar to FIG. 14 and provided with aplastic sheath that extends from the distal end of the handpiece;

[0032]FIG. 16 is an enlarged, partial, cross-sectional view of yetanother device embodying the present invention similar to that shown inFIG. 14 but with a different fluid flow pattern;

[0033]FIG. 17 is an enlarged, partial, cross-sectional, side elevationalview of another alternate embodiment of the device of FIG. 1;

[0034]FIG. 18 is a cross sectional view of an alternate catheter insertembodiment taken along plane C-C in FIG. 19;

[0035]FIG. 19 is an enlarged, partial, cross-sectional, side elevationalview of the distal end of the device of FIG. 1 incorporating thecatheter insert embodiment of FIG. 18;

[0036]FIG. 20 is an enlarged, partial, cross-sectional side elevationalview of yet another embodiment of the device of the present invention;

[0037]FIG. 21 is an enlarged, partial, cross-sectional, side elevationalview of the distal end of the device of FIG. 20 with an inflatableballoon surrounding the distal end;

[0038]FIG. 22 is an enlarged, partial, cross-sectional, side elevationalview of yet a further embodiment of the device of the present inventionand depicting one flow pattern of a fluid therethrough;

[0039]FIG. 23 is an enlarged, partial, cross-sectional, side elevationalview of an alternate embodiment of the device of FIG. 20 incorporating acatheter insert and depicting an alternate flow pattern of a fluidtherethrough; and

[0040]FIG. 24 is an enlarged, partial, cross-sectional side elevationalview of yet another embodiment of the present invention;

DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

[0041] While this invention is susceptible of embodiment in manydifferent forms, specific embodiments are shown in the drawings and aredescribed herein in detail, with the understanding that the presentdisclosure is to be considered as an exemplification of the principlesof the invention and is not to be limited to the specific embodimentsillustrated.

[0042] An apparatus aspect of the present invention is a medicalcatheter device for delivering localized energy to a tissue in apatient's body in an amount sufficient to ablate or vaporize the tissue.In use, the catheter device is suitably positioned within a patient'sbody by insertion through a body lumen, cavity or surgically createdpassageway, and advanced to a predetermined site within the body. Thedevice of the present invention is particularly suited for thevaporization of prostate tissue and involves the use of laser energy.

[0043] FIGS. 1-3 illustrate one embodiment of a catheter device 100constructed in accordance with the present invention. The device 100incorporates an elongated quartz or fused silica optical fiber 1extending from a connector 2 which optically couples the optical fiber 1to a source of laser energy 3 through an elongate tubular handpiece 4and a hollow elongate generally cylindrically shaped metal tube 5 whichextends distally and co-axially from the handpiece 4. A proximal end oftube 5 extends at least partially through the handpiece 4 and is securedtherein. The distal end of tube 5 is closed ended and shaped, forexample, into a sharp needle point 6 to facilitate the penetrationthereof into the area of the tissue to be vaporized. Handpiece 4 bears atactile button 7, located on the side of handpiece 4 opposite thedirection of laser beam emission, as shown by the arrows, from a laseremission port or aperture 8 formed in the lower peripheral distal endwall portion of tube 5.

[0044] Surrounding and mounted to the proximal end of tube 5, adjacentthe handpiece 4, is a hollow fixture or fitting 9 which couples thehandpiece 4 to tube 5 and, as shown in FIG. 3, defines an interiorcavity 9 a in fluid or gas flow communication with an inlet port oraperture 20 formed in a lower proximal end wall portion of tube 5. Thefitting 9 has a hollow elongate arm or port 10 depending downwardlytherefrom and terminating in a luer lock 11 adapted for connection to asource of fluid or vacuum (not shown). Tube 5 also includes a fluidoutlet port or aperture 12 (FIG. 1) formed in a lower wall portionthereof and positioned approximately 30 cm proximal of the laser energyemission port or aperture 8 thereon. Fluid outlet port or aperture 12may be positioned on the same side of the wall of tube 5 as the laseremission port 8 (FIG. 1), or on any other surface of the wall of tube 5.Markings 13 (FIG. 1) on tube 5 indicate, for example, in 1 cm or shorterintervals, the distance from laser emission port 8 along the shaft oftube 5.

[0045] As seen in FIG. 2, optical fiber 1 extends generallylongitudinally through the handpiece 4, the fitting 9, the interior oftube 5 and terminates in tube 5 at a point opposite and generallyaligned vertically with the location of the laser emission port 8 suchthat the distal end of the fiber 1 is visible through the port 8. Theoptical fiber 1 is spaced from the interior surface of the wall formingtube 5 and thus is spaced and aligned generally parallel to the ports 8,12 and 20 formed in tube 5. The distal radial end surface of opticalfiber 1 has been ground to a flat 30° to 50° angle beveled surface 14,preferably a surface beveled at an angle of about 40°, which extendsangularly inwardly and proximally in the direction of the outlet port 12(FIG. 1) and facing away from laser emission port 8. The beveled surface14 allows laser energy emitted from the fiber optic 1 to be directedthrough the laser emission port 8 at an angle of about 80° to about 90°relative to the longitudinal axis of the fiber optic 1 and tube 5.

[0046] Optical fiber 1 includes a top buffer coat and underlying vinylcladding 15 which have been removed from the distal end portion thereofto define a bared distal fiber end portion. A quartz or fused silicacapillary tube 16, whose body is hollow and whose distal end is closedended, is disposed over and surrounds the bared distal end portion ofoptical fiber 1, and its proximal end may be affixed to bared opticalfiber 1 by thermal fusion or to buffer coat and vinyl cladding 15thereof by an adhesive. According to the present invention, capillarytube 16 prevents fluid from contacting the beveled distal end surface 14of optical fiber 1. An air interface or gap between the tube 16 and thebeveled surface 14 of optical fiber 1 is necessary for total internalreflection of the light energy, as shown by the arrows. Tube 5, whichmay be made of medical grade stainless steel such as used in syringeneedles may, as described above, have a sharp distal end terminating inthe point 6 as shown in FIG. 1, or a beveled distal end surfaceterminating in a point, as shown in FIG. 2, which is common in syringeneedles, to facilitate its entry into the tissue. To prevent tissue andblood from entering the open, beveled distal end of rod 5, the interiorof the distal end of rod 5 may be filled with an adhesive or otherbiologically compatible material 17.

[0047]FIG. 3 illustrates the means by which fluid may be infused intothe rod 5 to cool the distal end of tube 5 and capillary tube 16 andalso to clean any tissue debris from the light emitting quartz or silicasurface of capillary tube 16. Fitting 9 which includes a hollow interioror cavity 9 a is mounted for rotation about the tube 5, adjacent thedistal end of handpiece 4. “O” rings 18 create a seal between the hollowinterior 9 a and the proximal and distal ends of fitting 9 and tube 5.Fitting 9 has a hollow arm or elongate port 10 in fluid communicationwith an opening or port 19 in the lower wall of the fitting 9 which, inturn, is in fluid flow communication with the co-axially aligned inletopening or port 20 in tube 5. The arm 10 terminates in the standard luerlock 11, to which a source of fluid, such as a syringe pump, rollerpump, syringe or bag of fluid (not shown) may be attached. A pair offlanges or couplings 21, attached to and surrounding the tube 5, and inturn surrounded by the fitting 9, prevent fitting 9 from movinglongitudinally along tube 5. The “O” rings 18 surround the ends of thecouplings 21 and contact the interior surface of the wall of the fitting9.

[0048] Port 19 allows fluid to enter the space 9 a between the lumen offitting 9 and the exterior of tube 5, and port 20 allows fluid to enterthe space between the lumen of tube 5 and optical fiber 1, regardless ofthe axial position of fitting 9 on tube 5. Alternatively, suction may beapplied through the arm 10 of FIG. 3, utilizing a vacuum pump, a syringeor other means (not shown), as known in the art. All references to fluidinfusion herein also apply to the use of a vacuum or suction process.

[0049] While the use of a metal hollow tube 5 to enclose the beveledoptical fiber/capillary tube assembly is described herein, a plastictube or hollow rod (not shown) may be substituted for metal tube 5, witha short length of syringe needle attached to its distal end, tofacilitate the device's penetration into tissue. The distal end of thesyringe needle is plugged with an adhesive as described above.

[0050] As seen in FIG. 4(a), distal portion of tube 5 has, in oneembodiment, been flattened to the outer surface of the optical fiber 1at the 3 o'clock and 9 o'clock positions. The inner surface of the wallof the tube 5 is forced to contact the outer surface of the fiber 1 andto compress inwardly into an oval or elliptical shape so as to createupper and lower fluid channels or passageways 22 and 23 in the tube 5.

[0051]FIG. 4(b), which is a cross-section of the device of FIG. 2, takenthrough plane A-A, illustrates an embodiment where tube 5 is crimped tothe outer surface of fiber 1, thereby defining a pair of upper fluidchannels 22 and a pair of lower fluid channels 23.

[0052] The crimped distal end portion of tube 5 is shown in FIG. 5.Particularly, tube 5 is crimped generally from the proximal end of thecapillary tube 16 to the proximal end of tube 5 terminating in handpiece4. As shown in FIG. 5, channel 22 is in fluid flow communication withthe channel 23 and the inlet port 20 in tube 5 while the channel 23 isin fluid flow communication with the outlet port 12 in tube 5. Channel22 enables fluid to flow over the distal end of capillary tube 16 so asto cool and clean capillary tube 16 as well as metal tube 5, to flowinto channel 23 and exit therefrom via outlet port 12 in metal tube 5.Fluid channel 23 is plugged with adhesive 24 proximal to fluid exit port12 in the tube 5, and fluid exit port 12 has a width or diameter greaterthan the laser emission port 8 in the tube 5.

[0053] Fluid will take the path of least resistance in a generally ovalshaped pattern, as shown by the clockwise arrows, and flow through fluidchannel 22 in the direction of the distal end of the tube 5, over thetop surface of capillary tube 16, to counter any heat build-up on thetop (non-laser emitting side) of capillary tube 16 and tube 5, then overand around the distal laser emission surface of capillary tube 16, tocool it and wash away debris, then rearwardly thereof through the lowerfluid channel 23, and then out of the tube 5 through the fluid exit port12. Adhesive plug 24 in the portion of the channel 23 proximal to port12 (FIG. 5) prevents and blocks the further rearward flow of the fluidthrough the tube 5. Likewise, the adhesive blocks the flow of fluidthrough channel 23 upon introduction of the fluid through the inlet port20. Hot gasses, created by the vaporization of tissue by the laserenergy, may also enter laser emission port 8, travel rearwardly throughfluid channel 23 and exit tube 5 through fluid exit port 12 which, asdescribed above, is located at a point remote from the tissue beingtreated.

[0054] While a small amount of the infused fluid will be vaporized bythe laser energy as it passes over the laser emission surface ofcapillary tube 16, little, if any, of the infused fluid will exitthrough laser emission port 8, as the pressure created by hot gassesfrom the vaporization of tissue will force the fluid and the hot gassesthemselves to exit through the channel 23 and out through the fluid exitport 12. If these gasses are not allowed to exit, excessive coagulationof tissue and damage to the distal end of optical fiber 1, capillarytube 16 and tube 5 may result.

[0055] Alternatively, as shown in FIG. 6, if negative pressure isapplied to channel 22, fluid is drawn into channel 23 through the port12 and then flows in and around the capillary tube 16 in acounter-clockwise direction into channel 22.

[0056]FIG. 7 illustrates an alternate embodiment of the handpiece 4 ofthe device of FIG. 1 where the arm 10 is integrally associated withhandpiece 4 rather than fitting 9 (FIG. 3). As can be seen, opticalfiber 1 is affixed to handpiece 4 by adhesive 25 and extends through thehandpiece 4 and then tube 5, whose proximal end portion is affixed tohandpiece 4 by adhesive 26 and extends into and through a longitudinalgenerally cylindrically shaped interior cavity 4 a which extends fromthe distal end of the handpiece 4 into the body thereof. Button 7 may befriction fitted into a recess 7 a found in an upper portion of the outersurface of the handpiece 4 or fixed therein by an adhesive. Thehandpiece 4 includes a lower threaded aperture 4 b extending between thecavity 4 a and the lower outer surface thereof. The arm 10 incorporatesa threaded coupling 10 a for threadingly engaging threaded aperture 4 band securing the arm 10 to the handpiece 4. Tube 5 is positioned insidethe handpiece 4 such that the aperture 20 of tube 5 is positionedgenerally co-axially opposite and spaced from the aperture 4 b ofhandpiece 4.

[0057] In accordance with this alternate embodiment, fluid may beinfused in a manner similar to that described above with respect to FIG.5, through the female luer lock 11, through arm 10, through port 19 intocavity 4 a, through opening 20 in tube 5 and then into fluid channel 22.As described above, fluid cannot enter lower fluid channel 23, as it hasbeen occluded distally between the opening 20 and the exit port 12 withadhesive 24. Alternatively, negative pressure may be applied to luerlock 11 as described above with respect to the FIG. 6 embodiment.

[0058] As seen in FIG. 8, which depicts another embodiment of thehandpiece 4 and the fitting 9 of the device of the present invention,fitting 9 is rotatably attached to the proximal end of handpiece 4 asshown. The flange 27 in handpiece 4 extends circumferentially outwardlyfrom the distal end portion of handpiece 4 and defines circumferentialrecess 28. The end portion of the fitting 9 is fitted into the recess 28in the handpiece 4 for coupling the handpiece 4 to the fitting 9.

[0059] In this embodiment, the fitting 9 includes a longitudinal centralcavity 9 a in communication with a longitudinal central cavity 4 a inthe handpiece 4. The tube 5 and optical fiber 1 extend through therespective cavities 4 a and 9 a.

[0060] As described earlier in connection with FIGS. 3 and 7, fluid maybe infused through female luer lock 11, arm 1 0, opening 19 in fitting 9and opening 20 in tube 5, and into fluid channel 22 (fluid channel 23having been occluded by adhesive plug 24 in a manner similar to thatdescribed above). Tube 5 is affixed to handpiece 4 by adhesive 26.Gasket 29 surrounds the portion of the fiber 1 extending through theproximal end of the fitting 9 and forms a fluid seal to prevent fluidegress from the space between optical fiber 1 and the cavity 9 a infitting 9, while permitting fitting 9 to rotate about optical fiber 1,the proximal end of tube 5 and handpiece 4.

[0061] In this embodiment, handpiece 4 and attached tube 5, containingoptical fiber 1, can be rotated, without requiring the source of fluidor suction to be likewise rotated, reducing drag in the hand of theoperator. Alternatively, suction may be applied to luer lock 11.

[0062] As seen in FIG. 9, the device of the present invention mayalternatively incorporate a plastic elongated tubular insert 30, whoseinside diameter is only slightly larger than the outside diameter ofoptical fiber 1, and is extruded with at least two spaced apartlongitudinally extending tines, splines, fins or walls 31, preferablythree tines 31.

[0063] The insert 30 of FIG. 9, for example, may be extruded frommaterials such as polyvinylchloride (PVC), polyurethane, polypropylene,polyethylene or tetrafluoroethylene, e.g., Teflon®. A fluid such assaline may be infused into fluid inflow channel 22 as described above ata rate of about 1 to 10 cc per minute, preferably about 2 to 6 cc perminute.

[0064] As seen in FIG. 10, which is a cross-sectional view of the deviceof FIG. 11, taken through plane B-B, the tines or fins 31 extendperpendicularly outwardly from the outer surface of the insert 30 andare spaced around the circumference thereof. In the embodiment shown,the tines 31 are located generally at the 10 o'clock, 2 o'clock and 6o'clock positions of insert 30. As shown in FIG. 10, the optical fiber 1extends through the interior of the insert 30. The optical fiber1-plastic insert 30 assembly is disposed within the lumen or interior oftube 5, with the outer peripheral faces of the tines 31 contacting theinner surface of tube 5, to form the fluid inflow channel or passageway22 and two fluid outflow channels or passageways 23.

[0065] The distal end of insert 30 is positioned generally adjacent theproximal end of capillary tube 16 and aft of the emission port 8. Anadhesive or the like 24 is used to close both fluid outflow channels 23aft of the fluid exit port 12, which adhesive extends rearwardly andterminates just distally of the opening 20 in tube 5, as shown in FIG.5. The tines 31 are spaced about the outer surface of insert 30 suchthat the combined area of the lumens of the fluid outflow channels 23distal to fluid exit port 12 are significantly greater then the area ofthe lumen of fluid inflow channel 22. Also as seen in FIG. 5, fluid exitport 12 is larger than laser emission port 8, creating a path of leastresistance for fluid flow and hot gasses flowing out through the fluidexit port 12.

[0066] In a similar manner to that described above with respect to FIGS.3 and 7, fluid from a source (not shown) passes through fluid channel 22as shown by the clockwise arrows in FIG. 5 and cools the upper face ofthe closed distal end portion of capillary tube 16 which encases thedistal, beveled end of optical fiber 1 and tube 5, then passes around,cools and flushes debris from the laser emitting distal end surface ofcapillary tube 16, then through the two fluid channels 23 and then exitsthe device through fluid exit port 12, outside the area of tissue beingtreated. As also described above, the fluid cannot proceed furtherthrough fluid exit channels 23 due to adhesive 24, which is disposedtherein.

[0067] As shown in FIG. 11, arrow 32 indicates the direction of flow ofhot gasses resulting from the vaporization of tissue through laseremission port 8, into fluid exit channel 23 and then through the exitport 12. The pressure of hot gasses from the vaporization of tissue bylaser energy opposes fluid flow through channel 22 and does not permit asubstantial amount of the cooling fluid to exit through laser emissionport 8. In all of the described embodiments, fluid exit port 12 ispreferably located about 3 to 30 cm, preferably about 4 to 10 cm,proximal and aft of the laser emission port 8, a distance sufficient toplace the fluid exit port 12 outside of the area of the tissue beingtreated (i.e., outside the body or in the lumen of a vessel, duct, organor surgically created passage which is being cooled by fluid infusedindependently through an endoscope or catheter).

[0068] If a negative pressure is applied to channel 22, fluid is drawninto port 12 and hot gases from the vaporization of tissue are drawnthrough laser emission port 8. Both exit through channel 23 and passthrough the handpiece and fitting shown in FIG. 7 into a vacuumcollection bottle, syringe or other means, as is known in the art.

[0069] As seen in FIGS. 12 and 13, a thin plastic sleeve or sheath 33,preferably made of Teflon® or other lubricious, clear plastic material,may be disposed over and surround all but the distal end portion of thetube 5, to reduce friction with and prevent tissue adherence to the tube5. The distal end of sleeve 33 terminates at a point aft of the laseremission port 8. Also, sleeve 33 insulates the tube 5 and prevents heat,conducted along the tube 5, from coagulating tissue along the puncturechannel, causing edema and delaying healing.

[0070] While plastic sleeve 33 can be fixedly attached to tube 5, in theembodiment of FIGS. 12 and 13, plastic sleeve 33 is rotatable about tube5 and the handpiece 4. The proximal end of plastic sleeve 33 has beenformed and bent upwardly to form a circumferentially extending flange34, which is disposed and fitted within a circumferential recess 35extending inwardly into the body of the handpiece 4 from the innersurface of the handpiece 4 defining the cavity 4 a therein. Theflange/recess combination allows the sleeve 33 to be rotated relative tothe handpiece 4 and the tube 5. As shown, a port 36 formed in the wallof the plastic sleeve 33 is aligned with fluid exit port 12 of tube 5.In the position of FIG. 12, markings 37 and 38 located at the proximalend outer surfaces of the rod 5 and plastic sleeve 33 respectively, arealigned so as to align the sleeve port 36 with port 12 of tube 5.

[0071] As seen in FIG. 13, an external, side view of the device of FIG.12, markings 13 on tube 5, proximal to laser emission port 8, can beseen through plastic sleeve 33, enabling an operator to visually(through an endoscope) ascertain the depth to which tube 5 has beeninserted into tissue. As shown, sleeve 33 has been rotated 180° over thetube 5, so that fluid exit port 12 is covered by the sleeve 33. In thisposition, marking 37 on tube 5 and marking 38 on sleeve 33 are no longeraligned and are located on opposite sides of the tube 5. The ability toopen or close exit port 12 on tube 5 by rotating sleeve 33 enables fluidto be infused through fluid inflow channel 22 during all or the firstportion of the lasing procedure and, after rotating the plastic sleeve33 by 90° or more, preferably 180°, permits a vacuum to be drawn duringall or the second portion of the lasing procedure and, if desired,afterwards, to collapse the tissue whose inner portion has beenvaporized.

[0072] Alternatively, a vacuum can be drawn through channel 22 duringall or the first portion of the lasing procedure to evacuate the hotgasses created by vaporization of tissue and, after rotation of sleeve33, fluid to cool the distal end of the device can be infused during allor the second portion of the laser procedure through channel 22 and, ifdesired, afterwards to cool the tissue.

[0073] As seen in FIG. 14, the device of FIG. 1 may alternatively beconfigured such that fluid may be infused through the luer lock 11 of afirst arm 10, and suction may be simultaneously applied through a luerlock 11′ of a second arm 10′. In this embodiment, the arm 10 with luerlock 11 is operably and threadingly associated with the handpiece 4 inthe manner as described above with respect to FIG. 8. The second arm 10′with luer lock 11′ is operably associated with a fitting 9′ in themanner described with respect to FIG. 3 above and is mounted fore of thehandpiece 4. Particularly, tube 5 and optical fiber 1 extend firstthrough the cavity 9 a defined in the fitting 9 and then through thecavity 4 a defined in the handpiece 4 to define a device incorporatingtwo spaced apart arms 10 and 10′. The tube 5 incorporates a firstproximal port 20 in fluid flow communication with the first arm 10including luer lock 11 and a second distal port 20′ in fluid flowcommunication with the second arm 10′ including luer lock 11′.

[0074] In this embodiment, the portion of the outflow channel 23extending between the proximal port 20 and the distal port 20′ has beenblocked out or filled with an adhesive 24. In this embodiment, there isno fluid exit port in tube 5, and fluid is infused in a clockwisedirection through the arm 10 with luer lock 11, then through the variousports and cavities as described above with respect to the otherembodiments through the channel 22 and into and around the distal endportion of the capillary tube 16 as also described above to cool thetip. The fluid and hot gasses from the vaporization of tissue are thendrawn into the channel 23 by a vacuum which can be applied through luerlock 11′ and may be deposited in a vacuum collection bottle, a syringeor other device operably associated with the luer lock 11′ (not shown),by means known in the art.

[0075] In this embodiment, vacuum plus the pressure of gasses formed bythe vaporization combine to effect faster and more efficient removal offluid and hot gasses from the tissue opposite laser emission port 8.

[0076] An alternate, preferred embodiment of the present invention isshown in FIG. 15. In this embodiment, the proximal end of plastic sheath33 is fixedly attached within the distal end of the fitting 9′ of FIG.14 by adhesive 29. Sheath 33 has at least one port 36 near its proximalend, outside the body. Hot gasses from the vaporization of tissue enterthe space 39 between sheath 33 and hollow metal tube 5, as shown byarrow 39(a), and exit through port 36 in sheath 33 into the atmosphere.

[0077] As also seen in FIG. 15, fluid can flow through channel 22, asshown by arrows 31. Negative pressure is applied to channel 23, andfluid from channel 22 and hot gasses from the vaporization of tissue aredrawn into port 8 in metal tube 5, as shown by arrow 39(b), and passthrough channel 23, as described heretofore.

[0078] A more preferred embodiment of the device of the presentinvention is shown in FIG. 16, in which fitting 9, as shown in FIG. 14,is used to infuse fluid through channel 22, created by the space betweenoptical fiber 1 and the interior surface of metal tube 5. However, inthis embodiment, adhesive plug 24 shown in FIG. 14 is eliminated.

[0079] Fitting 9′ is rotatably disposed on metal tube 5. “O” ring 18creates a fluid tight seal between fitting 9′ and metal tube 5. Theproximal end of plastic sleeve or sheath 33 is fixedly attached withinthe distal end of fitting 9′ by adhesive 26. Sheath 33, in thisembodiment, has no ports in its proximal end.

[0080] In use, fluid is infused through fitting 9 into channel 22, aboutoptical fiber 1, at a rate of 1 to 10 ml per minute, preferably about 2to 6 ml per minute. Vacuum may be applied through fitting 9′ to draw hotgasses from the vaporization of tissue and any fluid not vaporized bythe laser energy into the space between tube 5 and the interior ofsheath 33.

[0081] This embodiment is simpler to manufacture and more efficientlyremoves excess fluid and hot gasses from the vaporization of tissue fromthe target area.

[0082] Instead of beveling the distal end of the optical fiber 1 at anangle of about 30° to 50°, preferably about 39° to about 40°, andencasing it in capillary tube 16 to obtain total internal reflection, asshown in FIG. 17, a reflector composed of gold, silver, copper or otherhighly reflective material 40 is disposed within the distal end of metaltube 5, whose distal end has been formed into a sharp point 6, or into abeveled syringe shape as shown in FIG. 2. The beveled surface 41 ofreflective material 40 is located opposite and spaced from the distalend of optical fiber 1 and generally above the tube emission port 8 andis inclined at an angle of approximately 35° to 55°, preferably at anangle of about 45°, opposite the end face of optical fiber 1, to directthe laser energy through the laser emission port 8 at an angle of about90° relative to the longitudinal axis of the fiber optic 1 and the tube5 as shown by the dotted lines. Such devices are more fully described inco-owned U.S. Pat. Nos. 5,242,437, 5,380,317 and 5,649,924, which arefully incorporated herein by reference. Silver is a preferred reflectivematerial, as it is about as efficient a reflector of holmium laserenergy as gold or copper, but is significantly less costly than gold andmore durable than copper.

[0083] Tube 5, has been crimped to optical fiber 1, as described in FIG.4(a), creating channel 22 and channel 23. A fluid, such as saline ordistilled water, may be infused through channel 22 in a similar manneras described above with respect to FIGS. 3 and 5 in a clockwisedirection around the distal end of the fiber optic 1 at a rate of about1 to 10 cc per minute, preferably about 2 to 4 cc per minute, to washany debris from the surface 41 of reflective material 40 and the tip ofthe optical fiber 1. Channels 23 enables hot gasses and steam from thevaporization of tissue and cooling fluid to escape through the exit port12 of tube 5.

[0084] Alternatively, a vacuum may be drawn through channel 23 in thesame manner as described above with respect to FIG. 6 to remove steamand hot gasses and prevent excessive coagulation of the target tissueand coagulation of tissue along the puncture channel. Although notdescribed in detail below, it is understood that the device of FIG. 17may be constructed to incorporate any of the previously describedhandpiece or fitting or sheath embodiments.

[0085] In bench testing, devices with a gold, silver or copperreflective material 40 exhibited a transmission efficiency ofapproximately 95% compared to a transmission efficiency of approximately90% for devices with an optical fiber whose distal end is beveled at anangle of about 39° to about 40° and encased in a capillary tube, asdescribed above.

[0086]FIG. 18 is a cross-sectional view of the device of FIG. 19, takenthrough plane C-C of FIG. 19. As seen in FIGS. 18 and 19, the insert 30of the device of the present invention may be substituted with an insert42 which is extruded of a solid plastic material such as described withrespect to the tube 30 and includes a central channel or bore 43 (FIG.18), just slightly larger in diameter than the diameter of the opticalfiber 1 which extends therethrough. The insert 42 additionally includesa separate top arcuate channel or passageway 22 which is formed in thematerial of the catheter 42 and is spaced from and partially surroundsthe channel 43. The catheter 42 also includes a bottom arcuate channelor passageway 23 which is also formed in the material of the catheter 42and also is spaced from and partially surrounds the channel 43. Thechannel 23 is larger in volume than the channel 22 and the channels 22,23 and 43 extend the length of the insert 42.

[0087] Channel 22 is in fluid flow communication with a source of fluidand channel 23 may be used for fluid outflow as shown by the clockwisearrows or may be in communication with a vacuum or suction source (notshown) both in the same manner as described above. Particularly, fluidflows into channel 22, as indicated by the clockwise arrows, and flowsover and around the distal end and emission surface of capillary tube 16and into lower channel or channels 23. Likewise, the arrows show thedirection of flow of hot gasses from the vaporization of tissue intoport 8, through channel or channels 23, and then into a collection means(not shown), as described heretofore. Plastic insert 42 may also beextruded with additional channels for these or other purposes.

[0088] As shown in FIG. 19, tube 5 can also include a tip or distal endportion 5 a which is secured to a body portion 5 b thereof by anoverlapping tongue and groove or the like structure 44 associated withthe distal end of the body portion 5 b and the proximal end of thedistal end portion 5 a.

[0089]FIG. 20 illustrates an alternate embodiment of the presentinvention. Instead of a prism-like refractive means or a gold, silver,copper or other metallic reflector means to deflect the laser energylaterally into the tissue away from the endothelial or urethral surface,this embodiment employs a means to deflect the distal end of the deviceat an angle of up to 90° or more into the target tissue in a very smallspace.

[0090] As seen in FIG. 20, the device 200 incorporates a plastic ormetal rod 45 having a central, longitudinally extending channel 46 whosediameter is larger than the outside diameter of optical fiber 48, whichis slidably disposed therein. Channel 46 transitions into a curved orarcuate channel 47, which curves toward and terminates outward in anopening 52 formed in the wall of the rod 45, at a point proximal to thedistal closed arcuate end thereof.

[0091] In this embodiment, the buffer coating 49 of optical fiber 48terminates about 2 to 10 cm from the distal end of optical fiber 48,preferably about 3 to 6 cm from its distal end, having been removedtherefrom by means known in the art, leaving the glass cladding (notshown) about optical fiber 48 intact.

[0092] A hollow cylinder 50 preferably made of a shape memory alloy suchas, for example, a superelastic nitinol, such as manufactured by Memry,Inc. of Menlo Park, Calif., which has been heat treated in a bentconfiguration at an angle up to 90° or more, preferably at least about30° to 80°, is attached, by crimping or an adhesive, as known in theart, to the bared distal end portion of optical fiber 48. The distal endof hollow cylinder 50 may be beveled into a sharp, syringe needleconfiguration 51. The distal end face of optical fiber 48 is preferablypositioned within the opening 51 of cylinder 50.

[0093] While hollow cylinder 50 is confined within channel 46 of rod 45,the cylinder 50 is constrained from its heat treated, curved shape. Whenthe distal end portion of hollow cylinder 50, containing bared opticalfiber 48, is manually advanced into curved channel 47 and out throughthe opening 52 in rod 45, by means located outside the body (not shown),cylinder 50 returns to its heat treated, curved shape, penetratesendothelial surface 53 and enters tissue 54 at a combined angle of up to90° or more.

[0094] Fluid may be infused or a suction may be drawn through the spacebetween the exterior surface of optical fiber 48 and the interiorsurface of hollow cylinder 50, or the space between the exterior ofcylinder 50 and the interior surfaces of channels 46 and 47. Optionally,a hollow sleeve 55 composed of a plastic, such as Teflon®, may extendover the exterior of hollow cylinder 50. Sleeve 55 prevents tissue fromsticking to the exterior of hollow cylinder 50, insulates the tissuefrom heat conducted along cylinder 50, and enables gasses from thevaporization of tissue to escape through the space between the exteriorsurface of hollow rod 50 and the interior surface of sleeve 55, as wellas between the tissue and the nonstick exterior of sleeve 55.

[0095] Such a device may be used to emit laser energy into the prostategland without damaging the male urethra and its underlying supportingtissue, as well as the esophagus in the region of the sphincter, or thefemale urethra beneath the bladder, without damaging their sensitiveendothelial lining.

[0096] If RF energy is emitted through metal electrodes inserted intotissue, the metal electrodes become very hot, conduct heat along theirlength and can damage the delicate endothelial surface of the tissueinto which they were inserted, for example, the urethral surface of theprostate, the endothelial surface of the esophagus in the area of thesphincter or the endothelial surface of the female urethra below thebladder. Fluid channels are needed to cool the endothelial surface andtemperature sensors at the endothelial surface are needed to sense thetemperature and halt the RF procedure if the damage threshold isreached. In addition to failing to complete the procedure, an expensivetemperature monitoring, display and control system is required, whichalso increases the risk of an electrical or computer malfunction.

[0097] As seen in FIG. 21, a balloon 56, which may be made of a materialsuch as latex, silicone, polyethylene or polyurethane, surrounds thedistal end portion of rod 45, distal and fore of the point at whichhollow cylinder 50, containing optical fiber 48 (not shown), exits theopening 52 in rod 45. Fluid may be infused as known in the art throughan elongate fluid channel 57 formed in and extending through the body ofthe rod 45 to inflate balloon 56. An opening 59 extending between thechannel 57 and the side wall of tube 45 allows for fluid communicationbetween the channel 57 and balloon 56. The portion of the channel 57located fore of the opening 59 is filled with an adhesive 58 to preventthe flow of fluid therethrough. Balloon 56 may be inflated with a liquidsuch as saline, a radio opaque or ultrasound opaque fluid or a gas, suchas air, CO₂, nitrogen or the like.

[0098] Balloon 56 centers and stabilizes rod 45 within the duct, holloworgan, cavity or passageway into which the rod 45 is inserted. If thedevice is used through the working channel of an endoscope, the locationof the balloon 56 fore of the rod opening 52 of rod 45 allows aphysician to see hollow cylinder 50 as it exits opening 52 and entersthe tissue. Markings 60 located on the exterior of cylinder 50 enablethe physician to observe how far cylinder 50 has been inserted into thedescribed tissue.

[0099] While one optical fiber 48, one hollow cylinder 50, one channel46 and one curved channel 47 are shown in the rod 45 of FIGS. 20 and 21,more than one of each of the above can be employed in rod 45. Also,curved channel 47 can be eliminated, with optical fiber 48 encased innitinol cylinder 50 exiting channel 46 directly out of the distal end ofrod 45. For example, to shrink or cause scarring in the tissuesurrounding the esophagus in the area of the sphincter, two, three, fouror more optical fibers 48 may each have their distal ends encased insuperelastic hollow nitinol cylinders 50 and each may be manuallyadvanced, together or separately, through channels 46 and 47 and intothe target tissue at an angle of up to 90° or more from the axis of rod45. In this application, rod 45 can have a diameter of about 2 to 16 mm,preferably about 3 to 12 mm. For use in the male urethra to vaporizetissue in the prostate, rod 45, containing one optical fiber 48 andcylinder 50 attached thereto, can have a diameter of about 1.5 to 4 mm,preferably about 2 to 3 mm. For use in the female urethra below thebladder to treat female stress incontinence, rod 45, containing oneoptical fiber 48 and one cylinder 50 attached thereto, can have adiameter of about 1 to 3 mm, preferably about 1.5 to 2.5 mm.

[0100] In an alternative embodiment, cylinder 50 may be eliminated andthe diatal end of optical fiber 1 may be beveled into a sharp point, toenable it to more easily penetrate tissue. Optical fiber 1 exits curvedchannel 47 at an angle in the range of about 20° to about 70° from theaxis of rod 45. Optical fiber 1 can contain markings 60 to enable anoperator to ascertain the depth to which fiber 1 has been inserted intotissue. Since optical fibers are not thermal conductors, fluid need notbe infused to cool the endothelial surface of the tissue into which theoptical fiber 1 has been inserted during lasing.

[0101] Yet another device embodiment 300 of the present invention isshown in FIG. 22, in which an optical fiber 61 is slidingly disposedwithin central channel 62 formed in plastic cannula 63, the distal endof which is beveled, like a syringe needle, to enable it to more easilypenetrate tissue. A wire 64, made preferably of nitinol, extends throughcentral channel 62 of cannula 63 and is affixed, as by adhesive or thelike, to the distal end of cannula 63 at joint 65 on the inner surfacethat defines channel 62.

[0102] The proximal end of wire 64 is attached to a retractable lever orspool within a handpiece (not shown), as known in the art. When thelever is retracted or the spool is turned, retracting or winding up wire64, the distal end portion of plastic sheath 63 may be bent orarticulated, up to about 90°, as shown.

[0103] When cannula 63 is inserted into tissue 66, laser energy can beemitted through optical fiber 61, or optical fiber 61 can be manuallyadvanced out of cannula 61 a desired distance. Preferably, optical fiber61 is advanced about 2 to about 8 mm into tissue 66, and laser energycan be emitted forwardly, as shown by the arrows.

[0104] Optionally, a fluid, such as saline, may be infused into centralchannel 62, as described above. The fluid flows, as shown by the arrows,through the space between optical fiber 61 and the inner surface ofcentral channel 62 and cools sensitive endothelial layer 67 of tissue66.

[0105] As shown in FIG. 23, optical fiber 61 extends through the centralchannel 62 of a plastic cannula 63, the distal end of which has beenbeveled, like a syringe needle, and which also contains channels 68 and69 similar in structure to the channels 22 and 23, respectively,described in FIG. 14, above. In this embodiment, a fluid, such as salinemay be infused through the smaller channel 68 to cool the endothelialtissue surface 67, and a vacuum or suction may be applied to the largerchannel 69 to remove hot gasses from the vaporization of tissue, in thesame manner as described above.

[0106] According to this embodiment, wire 64 extends from a retractingmechanism in a handpiece (not shown) through the larger channel 69 andis affixed to the distal end of plastic cannula 63 at point 65 on theinner surface of cannula 63. When wire 64 is extended, the distal end ofplastic cannula 63 is bent or articulated as shown in FIG. 23, enablingcannula 63, containing optical fiber 61 to enter tissue 66 at an angleapproximately perpendicular to endothelial surface 67 of tissue 66, asdescribed above. Optical fiber 61, optionally, can be advanced out ofcannula 63 a desired distance, up to 10 millimeters, into tissue 66,preferably 2 to 8 millimeters When laser energy is emitted through thedistal end of optical fiber 61, into tissue 66 as shown by the arrows, asubstantial amount of tissue may be vaporized or coagulated while thetissue underlying the endothelial surface 67 is not thermally damagedand the blood supply to the tissue underlying endothelial surface 67 ispreserved.

[0107] An alternate embodiment of the device of FIG. 21 is shown in FIG.24. In this particular embodiment, device 400 includes metal or plasticrod 70, whose distal end 71 is blunt or round ended and which containsinflation channel 72, which is in fluid communication with port 73. Theportion of channel 72 distal to port 73 is filled with an adhesive ofepoxy 74. The distal end portion of rod 70, including port 73 definedtherein, is encased within balloon 75. When fluid is infused throughchannel 72, balloon 75 is inflated to center and stabilize rod 70 withina duct, blood vessel, body cavity or surgically created passageway. Rod70 also contains channel 76, whose distal end portion is curved,preferably at an angle of 10° to 50° and exits rod 70 at opening or port77 in rod 70.

[0108] Optical fiber 78, which is disposed within metal sheath 79 havinga sharp distal end 83, which is like a syringe needle. Metal sheath 79may be made of medical grade stainless steel, but, is preferably made ofa shape-memory, nickel titanium alloy, whose distal end portion has beenheat treated into a curved shape, preferably at an angle of about 20° toabout 90°.

[0109] Metal sheath 79 is encased within a thin plastic sleeve 80 whichis preferably made of a lubricious material such as a fluorocarbon,e.g., a Teflon® material sleeve 80 enables sheath 79 to more easilypenetrate tissue, insulates and prevents heat conduction into tissue andprevents tissue from sticking to metal sheath 79.

[0110] Optical fiber 78, disposed within sheath 79, is moveably disposedwithin channel 76 of rod 70. When disposed within channel 76, metalsheath 79 is straight, as the stiffness of rod 70 exceeds the strengthof sheath's curvature. When optical fiber 78, sheath 79 and sleeve 80exit opening 77 of rod 70, sheath 79 is no longer constrained by rod 70and returns to its heat treated, curved shape, causing optical fiber 78to assume the same curvature. The combination of the curved distal endof channel 76 and the pre-formed curved shape of sheath 79 results inoptical fiber 78, sheath 79 and sleeve 80 entering tissue 81 at an angleof about 60° to about 110°, preferably about 70° to 90°. A vacuum may bedrawn through space 82 between optical fiber 78 and sheath 79 byconnecting the proximal end of sheath 79 (not shown) to a vacuum orsuction source (not shown), utilizing a fitting such as fitting 9 ofFIG. 3 or handpiece 24 of FIG. 16 (not shown).

[0111] When a vacuum is drawn through space 82 and laser energy isemitted through optical fiber 78, hot gasses from the vaporization oftissue are drawn into space 82, away from the target area within tissue81, into a collection bottle or other disposal means (not shown). Thisminimizes coagulation in the target area within tissue 81 and reducessubsequent edema.

[0112] While optical fiber 78 may be fixedly attached within metalsheath 79 and may have a flat distal end, so as to emit laser energyforwardly, in the embodiment shown in FIG. 24, optical fiber 78 ismoveably disposed within metal sheath 79 and is shown extended distallytherefrom. Also, optionally, the distal end of optical fiber 78 may bebeveled at an angle of about 30 to 50°, preferably about 39° to about40°. When laser energy is emitted from optical fiber 78 in a gasenvironment, which occurs after a few seconds of lasing, energy isemitted from optical fiber 78 by total internal reflection at an angleof about 70° to about 90° from the axes of optical fiber 78, as shown bydotted lines 84. In addition, optical fiber 78 may be rotated to createa larger vaporization zone in tissue 81.

[0113] Optionally, a metal or plastic band 85 may be attached to thedistal end of optical fiber 78, whose diameter is slightly smaller thanthe inner diameter of metal sheath 79. Band 85, when the distal end ofoptical fiber 78 is positioned within the distal end of metal sheath 79,prevents tissue from entering and clogging space 82 between opticalfiber 78 and the interior of metal sheath 79, when metal sheath 79 andoptical fiber 78 are being inserted into tissue 81.

[0114] Markings 86 on plastic sleeve 80 (or alternatively on metalsheath 79, which are visible through plastic sleeve 80) enable theoperator to ascertain the depth to which sheath 79, containing opticalfiber 78, has been inserted into tissue 81.

[0115] Alternatively, the distal end of sheath 79 may be similarlyarticulated or bent by a wire attached to the distal end of sheath 79and retracted by a ratchet or worm gear mechanism (not shown), as knownin the art.

[0116] Lasers which may be used with the device include argon, KTP,Nd:YAG, diode and others. However, these lasers, if fired at 60 wattsfor 30 seconds at each of 2, 4, 6 and 8 o'clock, create a largecoagulation zone (up to 1.5 cm in depth) and little vaporization.Excimer lasers are efficient vaporizers, but are expensive and oflimited power. Pulsed Alexandrite lasers, emitting at about 755 nm,modified Nd:YAG lasers emitting at about 1440 nm and holmium:YAG lasersemitting at about 2100 nm, are preferred for vaporization of tissue,with holmium:YAG being most preferred. If holmium:YAG laser energy is tobe employed, the optical fiber should be made of quartz or fused silicawith a low hydroxyl (—OH) content. If an excimer laser is to be used,the optical fiber should be made of quartz or fused silica with a highhydroxyl (—OH) content. Optical fibers which can be used in the deviceof the present invention can have a core diameter of about 200 to 1,000microns, preferably about 300 to 600 microns.

[0117] For use in the prostate, the devices of FIGS. 1-19 or FIG. 24 maybe inserted into a lobe of an average sized (30 to 40 gram) prostate,with its distal end always at least 0.5 cm beneath the surface, andoriented to fire away from the urethra. For example, a holmium:YAG lasergenerating 60 watts of power (3 joules per pulse at a repetition rate of20 pulses per second) for five to sixty seconds, preferably about ten toforty seconds, may be used with constant (saline) flow of about 2 to 6cc per minute, while rotating the tip of the device through a 90° arc atone or more points about 1 cm apart within the lobes of the prostate(from the veru montaneum to the bladder neck). The device may be rotatedthrough a 90° arc at a rate, for example, of about 90° per second, oradvanced and withdrawn while lasing within the lobe at a rate of about 1cm per second. The metal tube may be first inserted, for example, in theleft lobe of the prostate at 2 o'clock and the above described lasingprocedures performed. The metal tube insertion and lasing procedureswould then be repeated at 4 o'clock in the same lobe, at 8 and 10o'clock in the right lobe and, if desired, at 6 or 5 and 7 o'clock inthe median lobe, if it is significantly enlarged. The method of use ofsuch devices is described in co-owned U.S. Pat. No. 5,437,660,incorporated herein by reference.

[0118] At 3 joules per pulse and 20 pulses per second (60 watts) forfifteen seconds, with a device such as shown in FIG. 15, with a plasticsleeve 33, fluid flow and rotation as described above, a Holmium laserwill produce a vaporization zone in tissue of about one cm in diameterin each lasing position. If there are a total of 12 lasing positions,approximately 12 cc of tissue will be vaporized with minimal coagulationof tissue.

[0119] Lower power, for example 30 watts of Holmium:YAG laser energy (2joules per pulse at a repetition rate of 15 pulses per second) may beemployed for about 30 seconds to about 1 minute at each lasing position,for example with the device inserted at 2, 4, 8, 10 o'clock for anaverage sized prostate, and at 6 or 5 and 7 o'clock if the median lobeis enlarged.

[0120] The devices of FIGS. 20-23 may be inserted to a depth of at least0.5 cm into a lobe of the prostate and a similar amount of laser energymay be emitted. The procedure may then be repeated at about 1 cmintervals from the earlier puncture and lasing sites.

[0121] If a device of the present invention is used to vaporize a tumor,Excimer or holmium:YAG lasers are preferred. If it is desired tocoagulate the tumor in situ, an argon, KTP, diode or Nd:YAG laser may beused.

[0122] The side firing devices of FIGS. 1-19 and FIG. 24 may be insertedinto the center of the tumor if it is spherical, and energy may beemitted, for example, at a given level for the same amount of time at 3,6, 9 and 12 o'clock. If the tumor is ovoid, energy may be emitted, forexample at a given level of energy at 6 and 12 o'clock for 30 seconds,and at 3 and 9 o'clock for 15 seconds, producing an oval coagulationand/or vaporization zone. Alternatively, for an ovoid tumor, forexample, a given level of energy may be emitted for the same amount oftime at 2, 4, 8 and 10 o'clock. If the tumor is bean or crescent shaped,the device may be inserted at two or more points and fired, for example,at a given amount of energy for the same or a different amount of timein directions necessary to assure complete coagulation or vaporizationof the tumor.

[0123] If the tumor adjoins a vital blood vessel, duct, nerve or otherstructure, the device may be inserted between the blood vessel, duct,nerve or structure and fired away therefrom in one or more directions.In any case, if a shallower depth of vaporization or coagulation isdesired, the amount of energy and/or the amount of time may be varied.

[0124] Numerous variations and modifications of the embodimentsdescribed above may be effected without departing from the spirit andscope of the novel features of the invention. No limitation with respectto the specific apparatus illustrated herein is intended or should beinferred. The above description is, of course, intended to cover by theappended claims all such modifications as fall within the scope of theclaims.

We claim:
 1. A catheter device adapted for delivering laser energy to a body tissue comprising: a) an elongate hollow tube defining first and second spaced-apart ports; b) a flexible energy conduit adapted for connection to a laser energy source, extending through said tube and including a distal end adapted to emit laser energy to a predetermined tissue site and the distal end portion thereof defining a channel in said tube in fluid flow communication with said first and second ports respectively; and c) a fluid conduit for passing a fluid or creating a vacuum through said first and second ports and through said channel for cooling said distal end portion and cleaning said distal end of said energy conduit.
 2. The catheter device of claim 1 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said conduit for passing a fluid comprises a fitting defining an interior cavity in fluid flow a communication with a fluid source, said tube extending through said fitting; whereby said inlet port in said tube is located in fluid flow communication with said cavity in said fitting and the fluid flows through said channel and exits through said outlet port.
 3. The catheter device of claim 1 wherein said first and second ports in said tube comprise fluid inlet and outlet ports respectively and said fluid conduit for passing a fluid includes a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said handpiece; whereby said inlet port in said tube is located in fluid flow communication with said interior cavity and fluid flows through said channel and exits through said outlet port.
 4. The catheter device of claim 1 wherein said fluid conduit for creating a vacuum comprises a fitting defining an interior cavity in fluid flow communication with a vacuum source, said tube extending into said fitting; whereby said first port in said tube is located in fluid flow communication with said cavity in said fitting and said fluid flows successively through said second port, said channel and then through said first port in response to the creation of a vacuum in said tube.
 5. The catheter device of claim 1 wherein said fluid conduit for creating a vacuum comprises a handpiece defining an interior cavity in fluid flow communication with a vacuum source, said tube extending into said handpiece whereby said first port in said tube is located in fluid flow communication with said cavity in said handpiece and fluid is guided successively through said second port and said channel and then through said first port in response to the vacuum in said tube.
 6. The catheter device of claim 1 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively, said fluid conduit for passing a fluid comprising a handpiece defining an interior cavity in fluid flow communication with a fluid source and said tube extends into said handpiece and said fluid inlet port thereof is in fluid flow communication with said cavity in said handpiece, said fluid conduit for creating a vacuum comprising a fitting including an interior cavity in fluid flow communication with a vacuum source, said tube extending into said fitting and said fluid outlet port being in fluid flow communication with said cavity in said fitting whereby fluid is guided successively through said inlet port in said tube and said channel and then through said outlet port in said tube in response to the introduction of fluid through said inlet port and the vacuum through said outlet port.
 7. The catheter device of claim 1 wherein said tube includes an interior surface, said flexible energy conduit extending through an elongate insert which extends through said tube, said insert including an outer circumferential surface and a plurality of spaced-apart fins extending between said outer circumferential surface of said tube and said insert surface of said tube to define a first upper passage in said tube and a second lower passage in said tube together defining said channel in said tube.
 8. The catheter device of claim 1 wherein each said tube and said energy conduit includes opposed side surfaces and said opposed side surfaces of said tube are crimped respectively against said opposed side surfaces of said energy conduit to define a first upper passage and a second lower passage in said tube together defining said channel in said tube.
 9. The catheter device of claim 1 wherein said flexible energy conduit extends through a second tube which extends through said tube, said second tube defining a central elongate hollow passage through which said conduit extends and upper and lower elongate arcuate passages together defining said channel in said tube.
 10. The catheter device of claim 1 wherein said flexible energy conduit is an elongate fiber optic capable of delivering laser light to a body tissue, having a proximal end adapted for connection to a laser source, said tube including a third port through which the laser light is delivered to the body tissue at an angle of about 80° to 90° relative to the longitudinal axis of the device.
 11. The catheter device of claim 1 further including a sheath surrounding said tube and defining a port therein, said sheath being rotatable about said tube for aligning said port therein with said second port in said tube.
 12. A catheter device adapted for delivering laser energy to a body tissue comprising: a) a source of laser energy; b) an elongate hollow tube including a peripheral wall terminating in a distal closed tip and the peripheral wall defining first and second spaced-apart ports; c) an elongate fiber optic extending through said tube and including a distal end having a tip adapted to emit laser energy in a direction generally normal to the longitudinal axis of the device through a third port formed in said wall of said tube, and a proximal end adapted for connection to the source of laser energy, said fiber optic being spaced from said outer wall and said distal closed tip of said tube to define a fluid channel in said tube which surrounds said fiber optic; and d) means for introducing a fluid or a vacuum through said first and second ports and through said channel for cooling and cleaning said distal end of said fiber optic.
 13. The catheter device of claim 12 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said means for introducing a fluid comprises a fitting in fluid flow communication with a source of fluid and adapted for connection to said first port whereby fluid flows through said channel and exits through said second port in said tube.
 14. The catheter device of claim 13 wherein said fitting defines an interior cavity and said tube extends through said cavity whereby said first port is in fluid flow communication with said cavity.
 15. The catheter device of claim 12 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said means for introducing a fluid comprises a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said cavity of said handpiece such that said inlet port in said tube is located in fluid flow communication with said cavity and whereby said fluid flows through said inlet port and said channel and exits through said outlet port in said tube.
 16. The catheter device of claim 12 wherein said means for creating a vacuum comprises a fitting in fluid flow communication with a vacuum source and adapted for connection to said first port whereby fluid flows successively through said second port, said channel and then through said first port in response to the creation of a vacuum in said tube.
 17. The catheter device of claim 16 wherein said fitting defines an interior cavity and said tube extends through said cavity whereby said first port is in fluid flow communication with said cavity.
 18. The catheter device of claim 12 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively, said means for introducing a fluid comprising a handpiece including an interior cavity in fluid flow communication with a source of fluid and said tube extends into said handpiece and said fluid inlet port thereof is in fluid flow communication with said cavity in said handpiece, said means for creating a vacuum comprising a fitting in fluid flow communication with a vacuum source and adapted for connection to said second port whereby fluid flows through said inlet port in said tube and through said channel and exits through said outlet port in said tube in response to the introduction of fluid through said inlet port and the creation of a vacuum through said outlet port.
 19. The catheter device of claim 18 wherein said fitting defines an interior cavity and said tube extends through said cavity whereby said first port is in fluid flow communication with said cavity.
 20. The catheter device of claim 12 wherein said peripheral wall of said tube includes an interior surface, said flexible energy conduit extending through an elongate insert which extends through said tube, said insert including an outer circumferential surface and a plurality of spaced-apart fins extending between said outer circumferential surface of said insert and said interior surface of said wall of said tube to define a first upper passageway in said tube and a second lower passageway in said tube which together define said channel in said tube.
 21. The catheter device of claim 12 wherein each said tube and said energy conduit includes opposed side surfaces and said opposed side surfaces of said tube are crimped respectively against said opposed side surfaces of said energy conduit to define a first upper and a second lower passageway in said tube together defining said channel in said tube.
 22. The catheter device of claim 12 wherein said flexible energy conduit extends through a second tube which extends through said tube, said second tube defining a central elongate hollow passageway through which said conduit extends and upper and lower elongate arcuate passageways defining said channel in said tube.
 23. The catheter device of claim 12 further including a rotatable sleeve surrounding said tube and defining a port therein adjusted to be rotated into alignment with said second port in said tube.
 24. The catheter device of claim 12 wherein said tip of said distal end of said fiber optic is beveled to direct the laser energy generally normally outwardly through said third port in said tube and said distal end of said fiber optic is covered by a capillary tube including a closed distal end.
 25. The catheter device of claim 12 wherein said closed distal end of said catheter tube includes an interior beveled surface spaced from and opposite said distal end of said fiber optic for directing laser energy emitted from said fiber optic generally normally through said third port in said tube.
 26. A catheter device adapted for delivering laser energy to a body tissue comprising: a) an elongate hollow tube including a closed distal end and a distal peripheral end portion defining a port; b) an energy conduit extending longitudinally through said tube including a distal end spaced from and parallel to said port and adapted to emit laser energy; and c) means for directing the laser energy emitted from said distal end of said energy conduit outwardly through said port in said tube in a direction generally perpendicular to the longitudinal axis of said tube and said energy conduit.
 27. The catheter device of claim 26 wherein said distal end of said energy conduit includes a radial end face and said means for directing the laser energy comprises a surface on said radial end face of said energy conduit beveled at about a 39° angle.
 28. The catheter device of claim 26 wherein said closed distal end of said tube includes an interior radial face spaced from said distal end of said energy conduit, said means for directing the laser energy comprising a surface on said radial face beveled at about a 45° angle.
 29. The catheter device of claim 26 wherein said tube includes a peripheral wall defining first and second ports therein defining fluid inlet and outlet ports respectively and said conduit is spaced from said wall to define a fluid channel in said tube, said device further comprising a fitting in fluid flow communication with a source of fluid and adapted for connection to said first port whereby fluid is adapted to flow through said channel and exit through said second port in said tube.
 30. The catheter device of claim 26 wherein said tube includes a peripheral wall defining first and second ports therein defining fluid inlet and outlet ports respectively and said conduit is spaced from said wall to define a fluid channel in said tube, said device further comprising a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said cavity of said handpiece such that said inlet port in said tube is located in fluid flow communication with said cavity whereby said fluid is adapted to flow through said inlet port and said channel and exits through said outlet port in said tube.
 31. The catheter device of claim 26 wherein said tube includes a peripheral wall defining first and second ports and said conduit is spaced from said wall to define a fluid channel in said tube, said device further comprising a fitting in fluid flow communication with a vacuum source and adapted for connection to said first port; whereby fluid is adapted to flow successively through said second port, said channel and then through said first port in response to the creation of a vacuum in said tube.
 32. The catheter device of claim 26 wherein said tube includes a peripheral wall including an interior surface defining first and second ports formed therein and said conduit is spaced from said interior surface to define a fluid channel, said energy conduit extending through an elongate insert which extends through said tube, said insert including an outer circumferential surface and a plurality of spaced-apart fins extending between said outer circumferential surface of said insert, and said interior surface of said wall of said tube to define a first upper passageway in said rod and a second lower passageway in said tube which together define said channel in said tube.
 33. The catheter device of claim 26 wherein each said tube and said energy conduit includes opposed side surfaces and said opposed side surfaces of said tube are crimped respectively against said opposed side surfaces of said energy conduit to define a first upper and a second lower passageway in said tube together defining a channel in said tube in fluid flow communication with respective inlet and outlet ports formed in said tube.
 34. The catheter device of claim 26 wherein said distal end of said conduit is covered by a capillary tube including a closed distal end.
 35. A catheter device adapted for delivering thermal energy to a body tissue comprising an elongate flexible hollow catheter rod and a flexible energy conduit extending through said catheter rod and adapted to deliver the thermal energy to the body tissue, said catheter rod including a distal end portion adapted to be articulated from a generally longitudinal position to a bent position generally perpendicular to the body tissue.
 36. The catheter device of claim 35 further comprising a catheter tube including a distal end portion and an inner surface defining an elongate channel therein having a longitudinal segment and a unitary arcuate segment terminating in an opening defined in the distal end portion of said tube, said rod being slidably articulated through said channel and said distal end portion thereof being composed of a shape memory alloy adapted to maintain said generally longitudinal position when located in said channel and said bent position outside of said channel for delivery of thermal energy in an orientation generally perpendicular to the body tissue.
 37. The catheter device of claim 36 further comprising an inflatable balloon surrounding said distal end portion of said catheter tube, said arm further including an inner surface defining an elongate air channel in communication with said balloon for inflating said balloon.
 38. The catheter device of claim 35 further comprising an elongate wire having a distal end secured to the distal end portion of said catheter rod and being made of a shape memory alloy adapted to maintain either a first longitudinal position or a second curved position in response to the movement of said wire for respectively articulating said distal end portion of said catheter rod from said generally longitudinal position to said bent position.
 39. The catheter device of claim 38 wherein said catheter rod includes an interior surface defining a passageway through which extends said energy conduit, said wire extending through said interior surface of said catheter rod.
 40. The catheter device of claim 35 wherein said catheter rod defines an interior and said catheter device further includes an elongate insert extending through said interior of said catheter rod, said insert defining a central channel through which said energy conduit extends and first and second peripheral interior channels, said catheter rod further defining first and second spaced-apart ports in communication with said first and second channels in said insert, said first and second ports in turn being in fluid flow communication with a source of fluid and a vacuum respectively for delivering a fluid through said first channel and for evacuating the fluid through said second channel.
 41. A method for vaporizing an amount of tissue of a lobe of the prostate gland, without damaging the urethra or the tissue immediately underlying the urethra, comprising the steps of: a) advancing into a lobe of the prostate a hollow tube including a sharp distal end, said tube containing an optical fiber including a proximal end optically coupled to a source of laser energy and including a distal end face beveled at an angle of about between 30° to 50° from the axis of said optical fiber and encased in a fluid-tight capillary tube; b) positioning said tube so that a first port formed therein near its distal end and through which laser energy may be emitted is oriented away from the urethra and into the body of the lobe of the prostate and a second port is located on said tube outside of the lobe of the prostate; c) transmitting laser energy through said optical fiber of an amount sufficient to vaporize a portion of the lobe of the prostate; and d) simultaneous with transmission of laser energy, infusing a fluid through a fluid channel of said tube and drawing a vacuum through a second channel of said tube to cool the distal end of said tube and capillary tube and remove hot gasses and fluid from the vaporization zone of the lobe.
 42. The method of claim 41 wherein holmuim:YAG laser energy is transmitted through said optical fiber.
 43. The method of claim 41 wherein said distal end of said tube is positioned at least 0.5 cm beneath the surface of the urethra.
 44. A method of vaporizing the tissue of a lobe of a prostate gland comprising the steps of: a) advancing a hollow tube including a sharp distal end into a lobe of the prostate gland, said closed distal end of said tube including an interior radial face beveled at about a 45° angle and containing an optical fiber including a proximal end coupled to a source of laser energy; b) positioning said tube so that a first port, formed therein near its distal end and through which laser energy may be emitted, is oriented away from the urethra and into the body of the lobe of the prostate, said tube further including a second port located on said tube outside of the lobe of the prostate; c) transmitting laser energy through said optical fiber against said radial face of said tube and through said first port to vaporize a portion of the lobe of the prostate; and d) infusing a fluid through a first channel in said tube and drawing a vacuum through a second channel in said tube to cool said distal end of said tube and remove hot gasses and fluid from the vaporization zone of the lobe.
 45. The method of claim 41 wherein holmuim:YAG laser energy is transmitted through said optical fiber.
 46. The method of claim 41 wherein said distal end of said tube is positioned at least 0.5 cm beneath the surface of the urethra.
 47. A catheter device adapted for delivering laser energy to a body tissue comprising: a) a laser energy source; b) an elongate hollow tube defining first and second spaced-apart ports; c) a flexible energy conduit extending through said tube and including a proximal end adapted for connection to the laser energy source and a distal end adapted to emit laser energy to a predetermined tissue site, the distal end portion thereof defining a channel in said tube in fluid flow communication with said first and second ports respectively; and d) a fluid conduit for passing a fluid or creating a vacuum through said first and second ports and through said channel for cooling said distal end portion and cleaning said distal end of said energy conduit.
 48. The catheter device of claim 47 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said fluid conduit for passing a fluid comprises a fitting defining an interior cavity in fluid flow communication with a fluid source, said tube extending through said fitting; whereby said inlet port in said tube is located in fluid flow communication with said cavity in said fitting and the fluid flows through said channel and exits through said outlet port.
 49. The catheter device of claim 47 wherein said first and second ports in said tube comprise fluid inlet and outlet ports respectively and said fluid conduit for passing a fluid includes a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said handpiece; whereby said inlet port in said tube is located in fluid flow communication with said interior cavity and fluid flows through said channel and exits through said outlet port.
 50. The catheter device of claim 47 wherein the laser energy source is selected from the group consisting of an argon laser, a KTP laser, a Nd:YAG laser, a diode laser, an Alexandrite laser, and a holmium:YAG laser.
 51. The catheter device of claim 47 wherein the laser energy source is a holmium:YAG laser. 